title: Performance evaluation of the new rapid fertility assays in whole blood and plasma on PATHFAST.
abstract: BACKGROUND
  The purpose of this study was to evaluate the validity of the PATHFAST fertility marker assays for the rapid measurement of female hormones including: LH, FSH, Estradiol (E2), Progesterone (P4), Prolactin (PRL), and HCG. As for the PATHFAST fertility marker assays, female hormones can be measured by whole blood, plasma, and serum.
  
  
  METHODS
  The correlation of the heparin whole blood and the plasma samples in the PATHFAST was examined. The method comparison study of PATHFAST fertility marker assays was performed with the Elecsys 2010, AIA-360, IMMULITE 2000, miniVIDAS, and ARCHITECT i2000. Determination of the reference range values of the PATHFAST fertility marker assays was performed with serum samples which were obtained during the follicular phase, mid-cycle, luteal phase, and postmenopausal phase.
  
  
  RESULTS
  The results of plasma samples of female hormones measured by the PATHFAST correlated highly with those of whole blood samples (r > 0.9). The results of LH, FSH, E2, P4, PRL, and HCG as measured by the PATHFAST correlated well with other commercial fertility assays (r > 0.9). Reference values of PATHFAST fertility marker assays were equivalent to those of other commercial methods.
  
  
  CONCLUSIONS
  The PATHFAST system is an accurate diagnostic tool for the rapid assay of female hormones. The PATHFAST fertility marker assays can be useful in a physician's office laboratory (POL) as well as various clinical sites during infertility treatment.
authors.affiliation: Research and Development Division, Mitsubishi Chemical Medience Corporation, Chiba, Japan.
authors.forename: Yuuko
authors.initials: Y
authors.lastname: Sugie
authors.forename: Ko
authors.initials: K
authors.lastname: Igami
authors.forename: Keiichi
authors.initials: K
authors.lastname: Shoji
authors.forename: Nozomi
authors.initials: N
authors.lastname: Arai
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Tazaki
authors.forename: Hideki
authors.initials: H
authors.lastname: Kouta
authors.forename: Yoshikazu
authors.initials: Y
authors.lastname: Okamura
authors.forename: Shigeru
authors.initials: S
authors.lastname: Tashiro
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Yokoi
mesh_terms: D015415:Biomarkers / Q000097:blood; D019411:Clinical Laboratory Techniques / Q000379:methods*; D005260:Female; D005298:Fertility / Q000502:physiology*; D012739:Gonadal Steroid Hormones / Q000097:blood*; D006801:Humans; D007246:Infertility / Q000097:blood*; D012015:Reference Standards; D012680:Sensitivity and Specificity; D013997:Time Factors
chemical_list: D015415:Biomarkers; D012739:Gonadal Steroid Hormones